THE US could be about to halt the use of the Johnson & Johnson single-dose Covid vaccine over blood clot concerns.
Federal health agencies have called for use of the vaccine to be paused immediately today so that rare cases of blood clots can be investigated.
It comes after six recipients of the jab – out of almost seven million in the US – developed a rare disorder involving blood clots within about two weeks of vaccinations.
The FDA this morning tweeted: "Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
"As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare.
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered."
The move to pause the jab would be just a precaution, with the federal government to stop administration of the vaccine at all federally run vaccination sites, with state health officials expected to do the same.
On Wednesday, the CDC will convene at a meeting of the Advisory Committee on Immunization Practices to further review cases and assess their potential significance.
The FDA will then review that analysis as it also investigates the reported incidents.
"Until that process is complete, we are recommending this pause," the FDA added.
"This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."
'NO CLEAR CASUAL RELATIONSHIP'
Johnson & Johnson has said "no clear casual relationship" has yet been established between blood clot cases and the Janssen vaccine.
A statement from the company reads: "The safety and well-being of the people who use our products is our number one priority.
"We share all adverse event reports about individuals receiving out Covid-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards.
"We are aware that thromboembolic events including these with thrombocytopenia have been reported with Covid-19 vaccines.
"At present, no clear casual relationship has been established between these rare events and the Janssen Covid-19 vaccine."
The company has reassured that it will "continue to work closely with experts and regulators to asses the data and support the open communication of information to healthcare professionals and the public".
Almost seven million people in the US have so far received the Johnson & Johnson shot according to data from the Centers for Disease Control and Prevention.
Scientists with the Food and Drug Administration and Centers for Disease Control will examine possible links between the vaccine and the rare cases.
It will determine whether the FDA should continue to authorize use of the vaccine for all adults or limit it.
Meanwhile, a man in New Jersey has been hospitalized with Covid, just five weeks after being receiving a single shot of the Johnson & Johnson jab.
Francisco Cosme, 52, had his one-dose vaccine on March 6 and continued to wear a mask and social distance, reports the New York Post.
Just a few weeks later, however, on April 1Cosme tested positive for Covid and later became hospitalized after his condition worsened.
He remains in a critical condition at John F. Kennedy Medical Center, where he is also being treated for pneumonia.
It comes after Europe’s drug regulator the European Medicines Agency (EMA) launched a safety review into the jab after one person died from a blood clot after receiving the vaccine.
The Janssen jab is currently not in use in the UK, but could be by the summer.
At the end of February, the Food & Drug Administration granted emergency approval for Johnson & Johnson's Covid vaccine in the US.
It was considered a game-changer at the time since it only required one shot.
The other two approved vaccines — from Pfizer and Moderna — both require a booster.
The J&J approval has been instrumental in the country's ramped up efforts to get all American adults who want the vaccine access to it.
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